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Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments?

By: PQE Group

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Medicinal product clinical trials involving medical devices might be summarized in the following three cases: 

1.

The object of the study is one integral product which is a 'combination' of a medical device and a medicinal product, e.g., a pre-filled insulin syringe. 

Products that administer a drug shall be regulated as medicinal products where the device and the medicinal product form a Single Integral Product (including co-packaged and referenced). These products are covered by Medicines Legislation (Directive 2001/83/EC), although in addition to this, the relevant GSPR in Annex 1 of the MDR 2017/745 applies to the medical device.  

An exception is seen in the following situation:  

  • Devices incorporating, as an integral part, a substance, which, if used separately, may be considered to be a medicinal product, subject to the Medical Device Regulation 2017/745/EEC. 

For Case 1, the medicinal product dossier should include a discussion of the impact of the device on the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and overall control strategy of the medicinal product. 

If the device has a CE marking, then the applicant must provide a Declaration of Conformity or, where applicable, an EU Certificate issued by a Notified Body designated for the type of device in question, allowing the manufacturer to affix the CE marking to the device. 

If the device does not hold a CE marking and the dossier does not include a Declaration of Conformity or where applicable, an EU Certificate issued by a Notified Body designated, then the applicant must provide an opinion from a Notified Body on the conformity of the device with the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745. 
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2.

The object of the study is a medicinal product but during the clinical trial medical devices are used, e.g., a Companion Diagnostic device. 

In this case, two scenarios are allowed for the MD/IVD in subject: 

a. The device is CE marked, complying with the EU-rules for placing on the market and putting into service of medical devices Article 5 MDR EU/745/2017; 

b. The device is not CE marked. Then two possible options are available:
i. Article 5(5) MDR EU/745/2017 is applicable;
ii. Article 5(5) is not applicable. In this case the applicant must have the CE marking for the medical device. 

3.

The objects of the study are two separate products: one is a medicinal product and one is a medical device. 
a. For the aspects of the study having as object the medicinal product, Directive 2001/20/EC as replaced by REGULATION (EU) No 536/2014 is applied.
b. Regarding the medical device being the object of the study, Regulation EU/745/2017 is applied (Art. 62-80, Art. 82 and Annex XV). 

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